Senior Quality Control Microbiologist

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Jul 16, 2019
Ref
2019-3065
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

We are seeking a highly motivated individual to join us as a Quality Control Senior Microbiologist in our new gene therapy production center. You will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. This role will be a hands-on resource reporting to the QC Director of Microbiology. In this role you will be responsible for providing quality control technical support to QC and Manufacturing.

Responsibilities

  • Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
  • Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Train staff on technical concepts and methods.
  • Review laboratory data.
  • Perform other duties as assigned.


Qualifications

  • Bachelor's degree or advanced degree in Microbiology or related discipline.
  • A minimum of 8 years' experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years' experience with method and equipment validation within the biotechnology or pharmaceutical industry.
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell and gene therapy products.
  • Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP).
  • Experience in performing risk assessments.
  • Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation.
  • Extensive experience in conducting laboratory and environmental excursion investigations.
  • Strong knowledge of Equipment IQ/OQ/PQ/PV.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
  • Excellent interpersonal, verbal and written communication skills.
  • Experience managing projects.
  • Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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